Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Knee Osteoarthritis

NCT ID
NCT06608134
Registry status
Recruiting
Study type
Interventional
Phase
Early Phase 1
Sponsor
R3 Medical Research
Conditions
Osteoarthritis, Knee

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for

Enrollment: 120 participants (Estimated).

What is being studied

  • Biological: Umbilical Cord Wharton's Jelly Allograft Intra-articular Knee Injection

Who may be eligible

Ages
30 Years to no maximum
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion Criteria: * Be over age 30 * Diagnosed with Grade II or III OA on the KL scale (in one knee). * Body Mass Index (BMI) \<50Kg/m2 * Pain score of 4 or more on the Numeric Pain Rating Scale (NPRS) * Female patients must be abstinent, surgically sterilized or postmenopausal * Premenopausal females must have a negative pregnancy test, on contraceptive measures and do not anticipate pregnancy during the duration of the study. * Be willing and capable of giving written informed consent to participate in English. * Be willing and capable of complying with study-related requirements, procedures and visits in English. Exclusion Criteria: * Have taken any pain medication including nonsteroidal anti-inflammatory drugs (NSAIDs) within 2 weeks prior to study injection date. * Use anticoagulants have a substance abuse history and fail to agree not to take any knee-symptom modifying drugs during the course of the study without discussing and reporting the use to the site principal investigator and study team. * Have had an intra-articular injection of any drug including viscosupplementation in the index knee in the past 6 months. * Have had surgery on the index knee with the past 6 months. * Had a traumatic injury to the index knee with the past 3 months. * Planned elective surgery during the course of the study. * A history of organ or hematologic transplantation, rheumatoid arthritis, or other autoimmune disorders. * Be on immunosuppressive medications. * Have a diagnosis of carcinoma with the past 2 years. * Have a knee infection or have used antibiotics for knee infection within the past 3 months. * Have participated in any other clinical trial or treatment (not just for the knee, but for any reason) with any investigational product within the past 30 days prior to inclusion of study. * Female patients who are breast feeding or are pregnant or desire to become pregnant during the course of the study. * Contraindications to radiographic or MRI imaging. * Serious neurological, psychological or psychiatric disorders. * Injury or disability claims under current litigation or pending or approved workers compensation claims. * Have a known drug allergy to amphotericin-B, ciprofloxacin, gentamycin, penicillin, or streptomycin.

Study locations

5 study locations are listed.

Recruiting site status is explicitly provided for 5 locations; 5 are listed as Recruiting.

Countries: United States

  • Arizona, United States: 1
  • California, United States: 2
  • New York, United States: 1
  • Texas, United States: 1

Sample of listed locations

  • R3 Anti Aging Scottsdale — Scottsdale, Arizona, 85262, United States — Recruiting
  • R3 Anti Aging Beverly Hills — Beverly Hills, California, 90210, United States — Recruiting
  • Optimal Medical Group — Fresno, California, 93722, United States — Recruiting
  • Scheer Medical Wellness — New York, New York, 10036, United States — Recruiting
  • Dr. Duc (Steve) Le, MD — Cleveland, Texas, 77327, United States — Recruiting

Study details

Start date
October 1, 2024
Primary completion date
October 1, 2028
Completion date
October 1, 2029
First posted
September 23, 2024

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT06608134
Registry last updated
September 23, 2024
QualifiedStudies registry data refreshed
October 2, 2026
QualifiedStudies record fetched
October 2, 2026

View NCT06608134 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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